Class 2 Device Recall PRONOVA Nonabsorbable Suture, USP

• Date Initiated by Firm: May 07, 2018
• Create Date: July 17, 2018
• Recall Status: Terminated on June 08, 2020
• Recall Number: Z-2465-2018
• Recall Event ID: 80306
• 510(K)Number: K133356
• Product Classification: Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
• Product: PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Code Information: KJQ311 KKE670
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Ethicon Customer Support Center; 877-384-4266
• Manufacturer Reason for Recall: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
• FDA Determined Cause: Package design/selection
• Action: On May 24, 2018, the firm distributed Urgent: Medical Device Recall letters to affected U.S. customers. Customers were instructed to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-888-473-8015 or Ethicon3681@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall (removal). 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return all unused D-Special PROLENE¿ Polypropylene Suture & D-Special PRONOVA¿ Poly (Hexafluoropropylene - VDF) Suture products that are in their inventory immediately. Only D-Special PROLENE¿ Polypropylene Suture & D-Special PRONOVA¿ Poly (Hexafluoropropylene - VDF) Suture product subject to this recall (removal) returned by September 21, 2018 will be eligible for credit reimbursement. Any product subject to this recall (removal) returned after September 21, 2018 will not be eligible for credit reimbursement. 7. To return product subject to this recall (removal), photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for
• Quantity in Commerce: 144
• Distribution: Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAW and Original Applicant = ETHICON, INC.